PharmaCom BioVet, Inc. Begins To Review The Process To Potentially Receive Minor Use/Minor Species Drug Approval From FDA

Main Category: Veterinary
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Jun 2009 - 2:00 PDT

email to a friend   printer friendly   opinions  

PharmaCom BioVet, Inc. (PINKSHEETS: PHMB) is pleased to announce that the Company has begun the process to potentially apply and endeavor to receive a Minor Use/Minor Species (MUMS) drug approval from the Federal Drug Administration (FDA). Meeting the MUMS requirement is part of the New Drug Approval Process if the Company decides to potentially run clinical trials on a histone deacetylase inhibitor for canines with hemangiosarcoma, which the Corporation is considering the development of. The histone deacetylase inhibitor would be directed for dogs suffering from an acute type of cancer, canine hemangiosarcoma. The Minor Use and Minor Species Animal Health Act became law in 2004.

Minor uses are based on there being a small number of animals eligible for treatment with the product in question for the specific intended use. Small numbers have been determined for each of the 7 major species (cows, horses, pigs, chickens, turkeys, dogs, and cats). These have been published in a proposed rule (http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5385.pdf). To determine if a use is minor, the standard is that the intended use is for a "small number of animals." There is a different "small number" for each of the 7 major species and it reflects the number of animals affected by the disease over a one-year period.

"We are continuing to review the FDA filing requirements in order to determine if we may meet the requirements stated by the MUMS Act. By doing so, we potentially progress closer to being able to begin the testing of a novel cancer treatment for canines with Hemangiosarcoma," stated Gary S. Berthold, President of PharmaCom BioVet, Inc.



Source
PharmaCom BioVet, Inc.

• Additional
• References
• Citations